ZANIDIP 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

ZANIDIP 10 mg film-coated tablets

ZANIDIP 20 mg film-coated tablets

lercanidipine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Zanidip and what is it used for
2. What you need to know before you take Zanidip
3. How to take Zanidip
4. Possible side effects
5. Storage of Zanidip
6. Contents of the pack and other information

1. What is Zanidip and what is it used for

Zanidip, lercanidipine hydrochloride, belongs to a group of medicines called calcium channel blockers (of the dihydropyridine group) that lower blood pressure.

Zanidip is used to treat high blood pressure, also known as arterial hypertension, in adults over 18 years of age (it is not recommended for children under 18 years of age).

2. What you need to know before you take Zanidip

Do not take Zanidip

• If you are allergic to lercanidipine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If you have heart diseases such as: obstruction of blood flow from the heart, uncontrolled heart failure, unstable angina (chest pain at rest or progressively increasing) and during the first month after suffering a heart attack.
• If you have severe liver problems.
• If you have severe kidney problems or are undergoing dialysis.
• If you are taking certain medicines that inhibit liver metabolism, such as: antifungals (such as ketoconazole or itraconazole), macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin), antivirals (such as ritonavir).
• If you are taking other medicines containing cyclosporin (used after a transplant to prevent organ rejection).
• With grapefruit or grapefruit juice.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zanidip:

• If you have a heart problem.
• If you have liver or kidney problems.

You should inform your doctor if you think you are pregnant (or might become pregnant) or are breast-feeding (see section on pregnancy, breast-feeding and fertility).

Children and adolescents

The safety and efficacy of Zanidip have not been established in children under 18 years of age.

Other medicines and Zanidip

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because when Zanidip is combined with other medicines, the effect of Zanidip or the other medicine may change or the frequency of certain side effects may increase (see section 2 "Do not take Zanidip").

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• phenytoin, phenobarbital or carbamazepine (medicines for treating epilepsy)
• rifampicin (a medicine for treating tuberculosis)
• astemizole or terfenadine (medicines for allergies)
• amiodarone, quinidine or sotalol (medicines for treating heart rhythm disorders)
• midazolam (a medicine to help you sleep)
• digoxin (a medicine for treating heart problems)
• beta-blockers such as metoprolol (a medicine for treating high blood pressure, heart failure and abnormal heart rhythm)
• cimetidine (more than 800 mg, a medicine for ulcers, indigestion or heartburn)
• simvastatin (a medicine to lower blood cholesterol levels)
• other medicines for treating high blood pressure

Taking Zanidip with food, drinks and alcohol

• Fatty meals greatly increase the concentration of the medicine in the blood (see section 3).
• Alcohol may increase the effect of Zanidip. Do not consume alcohol during treatment with Zanidip.
• Zanidip should not be taken with grapefruit or grapefruit juice as it may increase the hypotensive effect. See section 2 "Do not take Zanidip".

Pregnancy, breast-feeding and fertility

It is not recommended to take Zanidip if you are pregnant and it should not be taken during breast-feeding. There are no data on the use of Zanidip in pregnant or breast-feeding women. If you are pregnant or breast-feeding, if you are not using an effective contraceptive method, think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

If you experience dizziness, weakness or numbness when taking this medicine, do not drive vehicles or use machines.

Zanidip contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

ZANIDIP contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; this is essentially "sodium-free".

3. How to take Zanidip

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults:The usual recommended dose is one 10 mg tablet daily at the same time each day, preferably in the morning and at least 15 minutes before breakfast. Your doctor may increase the dose to one 20 mg Zanidip tablet daily, if necessary (see section 2 "Taking Zanidip with food, drinks and alcohol").

Zanidip 10 mg: the score line is only to facilitate the breaking of the tablet and improve its ingestion, but not to divide it into two equal doses.

Zanidip 20 mg: the tablet can be divided into equal doses.

The tablets should be swallowed whole with a little water.

Use in children:This medicine should not be given to children under 18 years of age.

Elderly population:No dose adjustment is required. However, they may require special care at the start of treatment.

Patients with kidney or liver problems:Special care is required when starting treatment in these patients and an increase in the dose to 20 mg daily should be done with caution.

If you take more Zanidip than you should

Do not take more doses than prescribed.

If you have taken more Zanidip tablets than you should, consult your doctor immediately, go directly to the hospital or call the Toxicology Information Service, telephone (91) 562 04 20. Take the package with you.

Taking a dose higher than the correct dose may cause an excessive drop in blood pressure and the heartbeats may become irregular and faster.

If you forget to take Zanidip

If you forgot to take your tablet, do not take the forgotten dose. Then, continue the next day as your doctor had indicated.

Do not take a double dose to make up for forgotten doses.

If you stop taking Zanidip

If you stop taking Zanidip, your blood pressure will rise again. Consult your doctor before stopping treatment.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur when taking this medicine:

Some of these side effects can be serious.

If you experience any of these side effects, consult your doctor.

Rare (may affect up to 1 in 1,000 patients):angina pectoris (chest pain due to lack of blood in the heart), allergic reactions (with symptoms such as itching, rash and hives) and fainting.

Patients with pre-existing angina pectoris may experience an increase in frequency, duration or severity of these attacks with medicines of the group to which Zanidip belongs. Isolated cases of heart attacks have been observed.

Other possible side effects

Common (may affect up to 1 in 10 patients):headache, increased heart rate or palpitations (strong or rapid heartbeats), sudden reddening of the face, neck or upper chest, swelling of the ankles.

Uncommon (may affect up to 1 in 100 patients):dizziness, low blood pressure, heartburn, discomfort, stomach pain, skin rash, itching, muscle pain, increased urine production, weakness or fatigue.

Rare (may affect up to 1 in 1,000 patients):drowsiness, vomiting, diarrhea, hives, increased urination frequency, chest pain.

Frequency not known (cannot be estimated from the available data):gum swelling, changes in liver function (detected in blood tests), cloudy fluid (when performing hemodialysis through a tube into the abdomen), swelling of the face, lips, tongue or throat that may cause breathing or swallowing difficulties.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system: Spanish Pharmacovigilance System for Human Use Medicines:www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zanidip

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the blister and carton after EXP. The expiry date is the last day of the month indicated.

Store in the original package to protect the medicine from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zanidip:

• The active substance is lercanidipine hydrochloride. Each tablet contains 10 mg of lercanidipine hydrochloride (equivalent to 9.4 mg of lercanidipine) or 20 mg of lercanidipine hydrochloride (equivalent to 18.8 mg of lercanidipine).

• The other ingredients are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone K30, magnesium stearate.

Coating: hypromellose, talc, titanium dioxide (E171), macrogol 6000, iron oxide (E172).

Appearance of the product and contents of the pack

Zanidip 10 mg are yellow, circular, biconvex film-coated tablets, 6.5 mm in diameter, with a score line on one side.

Zanidip 20 mg are pink, circular, biconvex film-coated tablets, 8.5 mm in diameter, with a score line on one side.

Zanidip 10 mg is available in packs of 7, 14, 28, 35, 50, 56, 98, 100 tablets. Not all packs may be marketed.

Zanidip 20 mg is available in packs of 7, 14, 28, 35, 42, 50, 56, 98, 100 tablets. Not all packs may be marketed.

Marketing authorisation holder and manufacturer:

Marketing authorisation holder:

Casen Recordati, S.L.

Autovía de Logroño, km. 13,300

50180 Utebo (Zaragoza). Spain.

Manufacturer:

Recordati Industria Chimica e Farmaceutica S.p.A.

Via Matteo Civitali, 1

20148 Milan (Italy)

This medicine is authorised in the Member States of the European Economic Area under the following names:

Zanidip: Austria, Belgium, Denmark, Finland, Greece, Luxembourg, Spain, Sweden and United Kingdom.

Corifeo: Germany.

Zanedip: Italy.

Zanicor: Portugal.

Lerdip: Netherlands.

Date of last revision of this leaflet:June 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/